# K071914: Mercury Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Oct 12, 2007 after 93 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K082353: Mercury Spinal System (2009), 11 descendants of its own
- K083230: Mercury Spinal System (2008), 11 descendants of its own
- K091587: Mercury Spinal System (2009), 10 descendants of its own
- K141372: Mercury Spinal System (2014), 9 descendants of its own
- K151215: Mercury Spinal System (2015), 8 descendants of its own

## Recalls of this device
- Apr 9, 2015 · Class III · Z-1597-2015: Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked 
- Apr 17, 2009 · Class III · Z-1266-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1260-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1261-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1248-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1249-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1251-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1256-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1250-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1265-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1247-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1262-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1264-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1253-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1246-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1263-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1252-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1258-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1259-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1254-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1257-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Apr 17, 2009 · Class III · Z-1255-2013: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

## Indications for use
The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (Ti-Si) of skeletally mature patients. This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K071914
Methodology: https://510kreport.com/methodology